Opicapone is a selective, reversible and peripherally acting catechol-O-methyltransferase (COMT) inhibitor used as an adjunct to levodopa/carbidopa therapy in adults with Parkinson’s disease experiencing end-of-dose motor fluctuations. It is a small-molecule pharmaceutical active ingredient and is marketed in the United States under the brand name Ongentys. Opicapone is identified by CAS Number 923287-50-7, molecular formula C15H10Cl2N4O6, and molecular weight 413.17 g/mol (approximately 413.2 g/mol).
Opicapone was developed as a long-acting COMT inhibitor designed to reduce peripheral metabolism of levodopa. By inhibiting COMT, Opicapone helps increase levodopa availability and prolong its therapeutic effect. Its pharmacological action lasts for more than 24 hours, supporting once-daily administration when used as part of an appropriate Parkinson’s disease treatment regimen.
Opicapone has a chemically distinctive structure containing dichloropyridine N-oxide, 1,2,4-oxadiazole, nitrophenyl and catechol-type hydroxyl groups. PubChem gives the IUPAC name as 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxidopyridin-1-ium-3-yl)-1,2,4-oxadiazol-5-yl]-3-nitrobenzene-1,2-diol. Its molecular formula is C15H10Cl2N4O6, with a calculated molecular weight of 413.2 g/mol.
Opicapone is a small molecule rather than a peptide or biological API. Its molecular structure contains two chlorine atoms, four nitrogen atoms and six oxygen atoms. The molecule also contains phenolic hydroxyl groups and a nitro group, which contribute to its physicochemical and pharmacological properties.
Opicapone works by inhibiting catechol-O-methyltransferase (COMT), an enzyme responsible for the peripheral metabolism of catechol compounds including levodopa. Inhibition of peripheral COMT reduces levodopa conversion to inactive metabolites, thereby helping increase the amount of levodopa available for therapeutic action.
The long duration of COMT inhibition is an important characteristic of Opicapone. PubChem reports that following a 50 mg dose, COMT inhibition lasts for more than 24 hours. This pharmacological profile allows Opicapone to be administered once daily as an adjunct to levodopa/carbidopa therapy.
Opicapone is primarily associated with pharmaceutical products for Parkinson’s disease. It is used as an adjunct to levodopa/carbidopa in patients who experience end-of-dose “off” episodes or motor fluctuations. Clinical evidence has demonstrated its role in extending levodopa's therapeutic effect and reducing off-time.
Potential pharmaceutical and research applications include:
Quality evaluation of Opicapone API should include identity, assay, related substances, residual solvents, water content and other applicable physicochemical parameters. HPLC is particularly important for assay and related-substance testing, while spectroscopic methods such as IR and mass spectrometry can support identity confirmation.
Because Opicapone is an established pharmaceutical active ingredient, the applicable finished-API specification should be based on the relevant pharmacopoeial requirements, regulatory documentation and validated analytical methods. The CMS should not automatically convert research-grade purity values into official release specifications.
Commercial analytical references list Opicapone at high purity, but these values are material- and supplier-specific. Therefore, where an official universal numerical API limit cannot be verified, the product page should state that the parameter is specification-dependent rather than presenting an unsupported value.
PubChem identifies Opicapone as a solid small molecule and reports the molecular weight as 413.2 g/mol. Its chemical identifiers include CAS 923287-50-7, UNII Y5929UIJ5N, ChEMBL CHEMBL1089318 and DrugBank DB11632.
Published pharmaceutical references identify Opicapone as an orally administered COMT inhibitor. The marketed dosage form is an oral capsule, with the active ingredient used as an adjunct to levodopa/carbidopa in adults with Parkinson’s disease experiencing motor fluctuations.
Opicapone Bulk API is relevant to pharmaceutical formulation, generic drug development, analytical research and manufacturing programs involving COMT-inhibitor products. Technical documentation should consistently identify the API by its CAS number 923287-50-7, molecular formula C15H10Cl2N4O6 and molecular weight approximately 413.17 g/mol.
For API procurement and quality assessment, documentation should include the Certificate of Analysis, analytical specification, assay method, related-substance profile, residual-solvent information, water content and stability/storage information applicable to the actual batch.
An Opicapone API Manufacturer in India product page can target pharmaceutical buyers, formulation-development companies and research organizations looking for Opicapone bulk API and related technical information. Important SEO identifiers include Opicapone API, Opicapone API Manufacturer, Opicapone API Manufacturer India, Opicapone API Supplier, Opicapone Pharmaceutical API, Opicapone Bulk API, Opicapone CAS Number, BIA 9-1067 API, and CAS 923287-50-7.
Opicapone should be positioned specifically as a COMT inhibitor API for Parkinson’s disease pharmaceutical development, rather than as a general dopamine agonist or dopamine replacement API. Its primary pharmacological role is inhibition of peripheral COMT to support levodopa therapy.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |